A Pilot of a Personalized Circadian mHealth to Improve Sleep in Night Shift Workers
Part of paid clinical trials in Novi, Michigan.
- Sponsor
- Henry Ford Health System
- Study ID
- NCT06809335
- Status
- Recruiting
Conditions
- Shift Work Sleep Disorder
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Personalized circadian mHealth — OTHERSHIFT is a mobile application designed to improve sleep in night shift workers. The SHIFT mobile application is used to collect data from an Apple Watch to assess an individual shift worker's body-clock timing and make personalized recommendations of light exposure schedules that are designed to align the body-clock with the night shift work schedule.
Study Details
The goal of this project is to establish the evidence base for equitable accessibility and implementation of the precision sleep medicine mobile application, SHIFT.
Key Dates
- Start date
- Oct 23, 2023
- Status verified
- Feb 2026
- Primary completion
- Jun 30, 2027
- Completion
- Jun 30, 2027
Study Design
- Enrollment
- 300 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: SHIFT AppParticipants in this condition will receive an access code to download the mobile application and conduct an orientation to SHIFT and the study procedures with a study team member. They will then enter four weeks of study directed use of SHIFT where they are trained on a daily procedure of opening SHIFT at the beginning of their day and planning their day in accordance with the app recommendations. App usage (4 times per week) will be incentivized with weekly bonuses added to study compensation. Following the four weeks of study-directed use, participants will continue with self-directed use. At four months, participants will then complete a booster session with two additional weeks of study-directed use, followed by self-directed use until the end of the study. The structure with the booster session has evidence for maintaining treatment gains and is also in alignment with the commercialization plan.
- No Intervention: Waitlist ControlParticipants in this condition will only complete questionnaires for the initial eight months. Those who remain shift workers will have the option of receiving the SHIFT app and the option to complete follow-up surveys in the same manner as the SHIFT App condition.
Primary Outcome Measure
Establish the effect of SHIFT on stakeholder-centered outcomes. [ Time Frame: From enrollment to the 8 month point. ]
Central Contacts
- Philip Cheng, PhD248-344-7361
- Marleigh Treger, BS248-344-8028
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Henry Ford Columbus Medical Center | Novi | Michigan | 48377 |
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